Who Should Attend
This course is designed for Validation, Quality, IT, and Business personnel responsible for implementing and using regulated computer systems in the pharmaceutical, biotech and medical device industries. The course is of special value to personnel seeking experience with computer validation and issues associated with FDA regulated computer systems. The course is especially designed for attendees seeking a thorough introductory level of understanding, yet is also designed to be valuable to those with prior experience seeking to remain current with industry trends and approaches.
Learning Objectives
The course is designed to provide a thorough understanding of computer system validation. In addition, the course will address how 21 CFR Part 11 (electronic record/electronic signature requirements) fits into the validation process. The attendee will be familiar with expected content for computer validation deliverables through examination of example documents, as well as how to develop the validation rationale for a variety of circumstances.
Course Description
This course focuses on developing and implementing regulated computer systems with an appropriate level of documented evidence to satisfy FDA expectations. The course targets deliverable document content and how to avoid rework and unnecessary expense through a proactive approach. The core elements of a satisfactory computer validation program will be emphasized.
Topics to be discussed include:
- The regulatory expectations for computer validation
- Relevant FDA warning letters
- The tasks and deliverables expected for computer validation
- Why validation processes vary so much
- Strategies for practical, yet defensible computer validation
- Sops required for system operation and maintenance
- 21 CFR part 11 and it’s implications for common regulations
- An active discussion of part 11 examples and audience questions
- The implications of GAMP 5 on computer validation and how to transition from GAMP 4
- Auditing GXP computer systems and suppliers